Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

This study has been withdrawn prior to enrollment.

(low accrual)

Sponsor:

Stanford University

ClinicalTrials.gov Identifier:

NCT01492569

First Posted: December 15, 2011

Last Update Posted: June 12, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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This randomized pilot clinical trial studies giving acupuncture in reducing nausea and vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy.

Number of episodes of vomiting [ Time Frame: During the first 24 hours of chemotherapy ]

Severity of nausea as recorded on the visual analogue scale (VAS) [ Time Frame: During the first 24 hours of chemotherapy ]

Measured as a continuous variable for the mean episodes of emesis. The mean VAS nausea score will also be measured as a continuous variable. Measured using the Multinational Association of Supportive Care in Cancer (MASCC) antiemesis tool.

Secondary Outcome Measures:

Number of as needed (PRN) antiemetic medications needed [ Time Frame: After the first 24 hours of chemotherapy ]

Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.

Other: questionnaire administration

Ancillary studies

Procedure: electroacupuncture therapy

Undergo TAPS

Other Name: electroacupuncture

Sham Comparator: Arm II (TAPS at a non-P6 point)

Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.

Procedure: electroacupuncture therapy

Undergo TAPS at sham point

Other Name: electroacupuncture

Other: questionnaire administration

Ancillary studies

Detailed Description:

PRIMARY OBJECTIVE:

I. To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.

ARM II: Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

8 Years to 21 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient with a planned admission for at least 24 hours for highly emetogenic or moderately emetogenic chemotherapy at Lucile Packard Children's Hospital or Packard El Camino.

Planned to undergo at least 2 more cycles of chemotherapy.

Can include but not limited to: children with high risk ALL, AML, Ewing's Sarcoma, Osteosarcoma

History of vomiting with prior cycles of chemotherapy (2 episodes of emesis at minimum) despite use of conventional antiemetic medications.

Age 8-21.

Parent must be able to understand and willing to sign written informed consent document.

Exclusion Criteria:

Prior knowledge of acupuncture or experience with acupuncture or acupressure.

There will be no restrictions regarding use of other Investigational Agents.